FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1926036
·
Received November 10, 2010
Report
- Report Number
- 3004209178-2010-09225
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 22, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT PT'S DEVICE HAD IMPEDANCE READINGS >4000 OHMS ON ALL OF THE BIPOLAR AND UNIPOLAR PAIRS. FURTHER INFO WILL BE REPORTED WHEN AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | IMPLANTED:| PROGRAMMER: MODEL 3031A, LOT # NGM029133P| IMPLANTED:| EXTENSION: MODEL 3095, LOT # NAH027745V| IMPLANTED:| LEAD: MODEL 3889, LOT # V008904 |